Reaction product of arginine and p-aminobenzoic acid, cosmetic, and human and animal health compositions thereof

ABSTRACT

A method of controlling the regulatory mechanism in humans that governs cell division in a damaged cell structure which comprises reactivating the proliferative phase regulated by DNA, to enable the damaged cell to redifferentiate itself according to its basic genetic code, by administering to the human the reaction product of arginine and p-aminobenzoic acid. A method in which said reactivation process suppresses sexual inflammations, enhances positive neural responses, precludes aggressive bacterial infections, promotes internal wound healing, and/or provides an infusible treatment for non-specific prostatitis.

This application is a continuation-in-part of patent application Ser.No. 09/020,284, field Feb. 6, 1998, now U.S. Pat. No. 6,365,167.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to cosmetic and human and animal healthcompositions, and, more particularly, to the reaction product ofarginine and p-aminobenzoic acid (PABA), and compositions thereof,useful for treating wounds, lesions, burns, sunburn, the hair and scalp,hemorrhoids and teeth, in animals and humans, including bovine mastitis.

2. Description of the Prior Art

The prior art does not disclose the reaction product of arginine andp-aminobenzoic acid (PABA), and cosmetic and health compositions andformulations thereof. For example, U.S. Pat. No. 4,499,067 disclosesonly acyl arginine derivatives without PABA; U.S. Pat. No. 4,921,939discloses only forming guanidine sweetening agents by reaction ofsubstituted arcyl amines with guanidino moieties; U.S. Pat. No.5,110,797 discloses peptide substituted/reacted arginine, however,without PABA; and U.S. Pat. No. 5,298,647 discloses PABA/amino acidreaction products which may be used as ultraviolet protecting agents,but arginine is not disclosed.

SUMMARY OF THE INVENTION

A method of controlling the regulatory mechanism in humans that governscell division in a damaged cell structure which comprises reactivatingthe proliferative phase regulated by DNA, to enable the damaged cell toredifferentiate itself according to its basic genetic code, byadministering to the human the reaction product of arginine andp-aminobenzoic acid.

DETAILED DESCRIPTION OF THE INVENTION

The composition of the invention comprises the formulation given inTable 1 below:

TABLE 1 Composition of Invention Percent by Wt. Component SuitablePreferred Optimum Reaction product of 0.5-10  1-5 2.29 arginine andp-aminobenzoic acid (PABA) (as a powder, aqueous solution, gel oremulsion for example) Biotin   0-0.05 0.01-0.2  0.0066 CalciumPantothenate 0-5 0.1-0.5 0.33 Myoinositol   0-1.0 0.1-0.5 0.33

The reaction product of arginine and PABA is prepared as follows:

EXAMPLE 1 Reaction Product of Arginine and p-Aminobenzoic Acid

A solution of 10 g of p-aminobenzoic acid, 99% (Fluka-SAF 06940) wasprepared by dissolving the acid in 50 ml isopropanol (Fluka-SAF 59310)at 600C. with agitation. Then a slurry of 10 g of 1-arginine, 98% freebase (Fluka-SAF 11010) in 50 ml of isopropanol at 600C. was added to thesolution. The reaction product was filtered to yield 14 g of thereaction product, referred to hereinafter as arginine aminobenzoate.

A typical composition of the invention was prepared as follows:

EXAMPLE 2

A typical composition of the invention had the following active andinert ingredients therein.

TABLE 2 Percent by Wt. ACTIVE INGREDIENTS Reaction Product of Example 12.29 d-Calcium Pantothenate 0.33 myo-Inositol 0.33 d-Biotin 0.0066Thymine 0.000016 Guanine 0.000016 Cytosine 0.000016 Adenine 0.0000162.96% INERT INGREDIENTS AND PRESERVATIVES Deionized H₂O 70.57% Mixedoils Safflow oil (or equiv) 7.53 Persic oil 3.38 Tocopherol 1.17 Borageoil 0.72 Coconut oil 0.72 Tea tree oil 0.69 Lanolin 0.36 Lecithin 0.2214.79% 14.79 Glycerine 10.24 Carbopol 980 0.65 Tween 80 0.41 Aloe Vera(freeze dried) 0.33 Camphor (natural) 0.27 Methyl paraben 0.25 Zincperoxide 0.25 Pemulin TR1 0.16 Propyl paraben 0.1 Ethyl paraben 0.05Silver benzoate 0.025 Butylated hydroxytoluene 0.01 100.00%

A cream formulation was prepared as follows:

EXAMPLE 3 Cream Formulation Base (C)

to 50 ml glycerin

add with low shear agitation

500 mg methyl paraben and

150 ml deionized water,

continue agitation and add

2 g freeze dried aloe (Triarco),

2 g d-calcium pantothenate (Eastman),

2 g myo-inosital (Fluka-SAF 57576),

250 mg ethyl paraben,

400 mg propyl paraben,

100 mg silver benzoate,

40 mg (+) biotin (Fluka-SAF 14400),

100 mcg thymine 99% (Fluka-SAF 89310),

100 mcg guanine (Fluka-SAF 51010),

100 mcg cytosine (Fluka-SAF 30430), and

100 mcg adenine (Fluka-SAF 01830).

Cream

When all the dry ingredients are present in solution, add with low shearagitation

200 ml 2% mucilage Carbopol 980,

continue agitation, and add

part A-1 consisting of

100 ml part A

2.5ml Tween 80

500 mg methyl paraben

1 g Pemulin TR1

added and dissolved at low shear. Then, the resulting emulsion (partsA-1 & C) was neutralized with 14 grams of arginine aminobenzoate in 30ml deionized water, to provide a cream with a pH of 5.5. Then adjust thepH to 7.7 with 10 ml of 2.5N (10%) NaOH.

EXAMPLE 4 Mast Aid Intermammary

Add 1.25 grams zinc peroxide to the cream formulation of Example 3.

Mechanism of Action of Composition of Invention

The composition of the invention in human and animal health care isreferred to herein as the effective action of “Cell DifferentiationRegulatory Mechanism Response Enabling Composition” (CDRMREC). In suchresponse, the composition of arginine-PABA affects the regulatorymechanism that governs the process of cell division. When appliedtopically, the CDRMREC causes activation of the proliferative phase inthe DNA regulatory mechanism which speeds the rate of cellular responsein the process, for example, of wound healing. Additionally, thecomposition herein can accelerate the micro-circulation which affectsthe process of inflammation control at the site of injury. Thestimulation of micro-circulation by CDRMREC focuses the body's increasedhumoral response to trauma at the site of injury. This increase in thenatural micro-circulation also provides ancillary benefits such as thedebridement of necrotic tissue, removal of edema, and support ofaccelerated cell repair. CDRMREC also affects the chemistry surroundingthe micro-neuron receptors within damaged cells, thus controllingspontaneous pain at the actual site of injury without diminution ofother sensations.

When treated with the composition of the invention, lesions such asburns, ulcers, wounds, lacerations, and damaged, as well as normal skin,are observed to show the following responses:

1. Treated lesions show accelerated epithelialization.

2. Treated lesions show accelerated endothelialization.

3. Treated lesions show accelerated mesothelialization.

4. Treated lesions had a lack of scab formation.

5. Treated lesions rapidly form rolled edges.

6. Treated skin lacerations close in less than 4 hours.

7. Treated lacerations stop bleeding in less than 3 minutes.

8. Treated lesions such as burns, ulcers, wounds and lacerations showselective abatement of spontaneous pain without diminution of othersensation in the affected area.

9. Treated lesions epithelialize into pink unpigmented translucent skin.

10. All treated lesions show suppression or absence of cicatrixization.

The composition of the invention has proven effective in the treatmentor prevention of human and animal health problems as described below.

In topical form, CDRMREC has treated:

Wounds (small or large animals and humans).

Burns (small or large animals and humans).

Sunburn (in humans or sheep and dogs after shearing).

Non-specific vaginitis (large animals).

Dermatitis (small or large animals and humans).

Pyoderma (small or large animals and humans).

Rhabditic dermatitis (dogs and cattle).

Eczema Nasi of dogs.

Exudative epidermitis (pigs).

Pityriasis rosea (pigs).

Saddle Sores (horses).

Hutchburn (rabbits).

Dermal lesions (small or large animals and humans).

Udder edema (cattle, goats and sheep).

Abscesses (small or large animals and humans).

Burns

An excellent sunscreen with an SPF of 15 or better, CDRMREC reduced thepain and removed the redness of sunburn very rapidly. It moisturized dryand sunburned skin while promoting and prolonging a tan. CDRMREC alsoprevented blistering and peeling.

During the clinical test of CDRMREC by artificially induced sunburn, thetreated site changed color from red to brown almost immediately uponapplication. All erythema had disappeared within the first hour oftreatment. The pain at the CDRMREC treated site also disappeared in lessthan 5 minutes. The treated site did not peel and maintained its tan fora month after the control site had faded.

CDRMREC has reduced the pain and alleviated redness associated withburns (1st and 2nd degree). It moisturized burned skin (1st and 2nddegree) and rapidly facilitated healing of burns (1st, 2nd and 3rddegree) while preventing or suppressing blistering. When treating 3rddegree burns there was accelerated epithelialization and diminution ofscarring without formation of keloid tissue.

CDRMREC has successfully treated frost bite and wind burn.

Surface Wounds or Lesions

CDRMREC reduced the spontaneous pain (without dimunition of othersensation) at the site of injury and accelerated healing of surfacewounds, lacerations, lesions such as dermal ulcerations, dermatitis,psoriasis, eczema and like conditions. CDRMREC caused rapidepithelialization of those wounds, lacerations and lesions down to thedermal base. The formula has closed lacerations in less than 4 hours.The formula enhanced and accelerated skin surface circulation whilestopping bleeding at the wound site within 3 minutes. CDRMRECsubsequently diminished scabbing and scarring. The formula rapidlyreduced the swelling associated with sprains and bruises. The formulahas also rapidly removed the swelling and pain of bee and waspenvenomation.

An example in point is that of a 4 mm diameter by 5 mm deep traumaticavulsion ulcer. Commencing 10 minutes after the wounding, CDRMREC wasused to irrigate the lesion constantly over a 7-hour span. Bleeding atthe wound site stopped within the initial 2 minutes of CDRMREC usage.During the initial 10 minutes of CDRMREC irrigation, pain was markedlyreduced and the ulcer developed rolled edges. The lesion appeared to befilling in with epithelium during the first 3 hours. The ulcer seemed tohave completely epithelialized during the first 6 hours of CDRMRECapplication.

In the case of a 160-square centimeter decubitus stasis ulcer of16-months duration, CDRMREC application caused complete completeepithelialization in a 4-day time span. The CDRMREC solution was applied3 times a day and dressed with 2 layers of dry gauze and paper tape.

Hair and Scalp

CDRMREC treated dandruff, stopping its occurrence after the secondapplication. It reduced hair loss and stimulated hair follicles byenhancing surface circulation which aided in restoring follicularviability. There is anecdotal evidence of new hair growth after thetenth week caused by CDRMREC application on a daily basis.

Acne

CDRMREC was used successfully as an adjunct when treating acne. In olderskin it improved the tone and restored dermal eleasticity. CDRMRECremoved dead dermal cells and controlled or reduced wrinkles. Afterfacial peels it diminished the pain and speeded the recovery.

Hemorrhoids

CDRMREC in the form of a gelatin suppository, restored competence to theaffected venous valves in cases of bleeding hemorrhoids while stoppingthe bleeding within minutes of application. After an average of threedoses the hemorrhoids were reported to have disappeared.

Dental

CDRMREC stopped the bleeding and caused the gum to reattach to the toothsurface in several cases of periodontal gum disease.

Animals

CDRMREC treated frost bite in cows by repairing the surfacemicro-arterials in the teats and udder. It also treated mastitis withoutantibiotics and teat ulcerations in cows and prevented bacterialinfections in injured, lacerated udders which had become contaminatedwith fecal material.

The following field trials of CDRMREC are descriptive of these results:

CDRMREC was applied topically to a 64-sq. cm suppurating ulcer on thetop left hindquarter of a prize Flemish Giant rabbit. Within one hour ofapplication, the ulcer had ceased suppurating and was 75% filled in. Thefollowing morning (18 hours later), the ulcer was completely filled inwith healthy tissue. In 3 weeks, the area had regenerated its hair andappeared normal.

CDRMREC was applied topically to one badly chapped (bleeding) teat. Thechapped teat had been treated with Bag Balm over the preceding 3 dayswith no visible improvement. After the first application (pre-milking)the bleeding stopped immediately. The teat surface softened sufficientlyfor successful milking. After the milking, CDRMREC was reapplied to thechapped area and by the following morning, it was reported that thelesion was healed.

CDRMREC was applied topically to 4 chaffed and encrusted teats. Thecomposition was applied to the ends of the 4 encrusted teats after themilking. The following morning, the encrustation was reported to havevanished and the chaffing appeared to be less evident. There was nofurther application of CDRMREC or any other medication. Later, thechaffed area was reported healed.

CDRMREC was applied topically prior to milking, to a 49-sq. cm. chaffedand bleeding lesion on an udder. The bleeding stopped immediately lessthan 2 minutes). The lesion was recoated after the milking wascompleted.

The animals discomfort was evident prior to the first application ofCDRMREC. However, following the second application of CDRMREC, the cowshowed no signs of discomfort. There were no further applications ofCDRMREC. The following morning the lesion was greatly improved and laterthe lesion was reported healed.

CDRMREC was infused up the teat duct of all 4 quarters of a cow that hadclinical mastitis in the left hindquarter. The afflicted quarter hadbeen previously treated with erythromycin one time on the previous day,but the swelling still remained, and that quarter was not giving goodmilk. Additionally, because of a differential in the vacuum when milkingthe cow, infected discharge from the left hindquarter contaminated theleft fore quarter which then began to show symptoms of clinical mastitis(flaking in the milk). The left fore quarter had not been infused witherythromycin. Following only one infusion of 10 ml per quarter ofCDRMREC, it was reported the following morning that all 4 quarters werecompletely normal. All signs of swelling were gone. The milk from allquarters was normal and untainted.

Treatment with CDRMREC was commenced on a cow that had previously hadmastitis in the right hindquarter which resulted in a non-productivequarter. Treatment consisted of six 10 ml intramamery ductal infusionsof CDRMREC in the afflicted quarter following each milking. After thesixth treatment an improvement was observed in the quality of the outputof the afflicted quarter resulting in a change from a cheesy to a milkyconsistency.

The following on cows at a local farm, to further demonstrate theeffectiveness of the composition of the invention.

A Jersey cow was suffering from mastitis in the right forequarter andhad received an antibiotic infusion in that quarter. She had a hardswelling described as the size of a soft ball in the upper part of thequarter. The next day, after the PM milking, she received only one 10 mlinfusion of CDRMREC in each of her quarters.

An hour-and-a-half after the infusion, the swelling was observed to bereduced to the size of a tennis ball. On the following morning, theswelling was still present and estimated at golf ball size. Her milkappeared normal. Three days later, the swelling was still present andlike a flattened golf ball but the milk tested normal.

Another Jersey cow had a laceration about the size and shape of ahalf-dollar on the left side of the udder. She also had severe edema ofthe udder. The laceration was accidental and the edema was the result ofrecent calving. After the PM milking on the laceration was disinfected.Then 5 ml of CDRMREC was applied to the wound and a tape butterfly wasaffixed. The entire udder was then treated with 15 ml of CDRMREC whichwas massaged into the surface. In less than one-half hour, the edema wasobserved to have reduced by 50%. The following morning the edema hadreduced to 85% of its original size. The laceration had softened but theflap had not reattached. At AM milking 4 days later, the flap had stillnot reattached nor had the edema reduced any further. 3 days later, theflap was cut-off. The underlying lesion filled in with normal tissuewithin a 2-day period, and the edema had disappeared.

Yet another Jersey cow had severe edema of the udder due to recentcalving. After the PM milking, 10 to 15 ml of CDRMREC was massaged intothe entire surface of the udder. In less than one-half hour, the edemahad reduced by 50%. The next day the edema had reduced to 85% of itsoriginal size, and, a week later, the edema disappeared.

While the invention has been described with particular reference tocertain embodiments thereof, it will be understood that changes andmodifications may be made which are within the skill of the art.Accordingly, it is intended to be bound only by the following claims, inwhich:

What is claimed is:
 1. A method of controlling the regulatory mechanismin humans that governs cell division in a damaged cell structure whichcomprises reactivating the proliferative phase regulated by DNA, toenable the damaged cell to redifferentiate itself according to its basicgenetic code, by administering to the human the reaction product ofarginine and p-aminobenzoic acid.
 2. A method according to claim 1 inwhich said reactivation process suppresses sexual inflammations,enhances positive neural responses, precludes aggressive bacterialinfections, promotes internal wound healing, and/or provides aninfusible treatment for non-specific prostatitis.